DopaFuse (levodopa/carbidopa continuous-release) / SynAgile - LARVOL DELTA

Non-invasive, continuous oral delivery of solid levodopa-carbidopa for management of Parkinson's disease. (PubMed, Sci Rep) - "The paste is delivered to the lingual side of the teeth where it is mixed with saliva and swallowed. As reported elsewhere, a 15-day, 16 patient open label clinical trial of the drug delivery system continuously extruding LD-CD paste significantly reduces the variability of the plasma LD concentration and alleviates symptoms of advanced Parkinson's disease (PD) as compared to LD-CD tablets."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Continuous Levodopa Delivery with an Intraoral Micropump System: An Open-Label Pharmacokinetics and Clinical Study. (PubMed, Mov Disord) - P2 | "Continuous delivery of LD/CD using the DopaFuse system was associated with significantly less variability in plasma levodopa concentrations and reductions in OFF time compared to treatment with standard oral LD/CD therapy and was well tolerated."

Journal • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease

Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: IRCCS San Raffaele Roma | Phase classification: P2a ➔ P2

Metastases • Phase classification • CNS Disorders • Movement Disorders • Parkinson's Disease

"#AAN2023 #AANAM Called DopaFuse, the experimental device is designed to deliver the levodopa and carbidopa into the mouth through a micropump within a wearable retainer. https://t.co/cPu541NtO3" (@Medscape)

CNS Disorders

Continuous Delivery of Levodopa/Carbidopa Using the Intra-Oral DopaFuse System: A Safety, Tolerability, PK and Efficacy Trial (AAN 2023) - "Continuous delivery of LD/CD using the DopaFuse System was well tolerated. Dopa Fuse was associated with significantly less variability in plasma levodopa and significant improvement in measures of motor function and ADLs in comparison to treatment with standard intermittent LD/CD."

Clinical • Late-breaking abstract • Movement Disorders

SynAgile Corporation Announces Positive Phase 2 Top Line Results for DopaFuse Levodopa-Carbidopa Delivery System (GlobeNewswire) - P2 | N=17 | NCT04778176 | Sponsor: SynAgile Corporation | “SynAgile Corporation…announced positive results from its Phase 2 clinical trial of continuous levodopa-carbidopa (LD-CD) administration using SynAgile’s proprietary DopaFuse® delivery system...All primary endpoints were met. Plasma LD variability was significantly reduced with DopaFuse compared to standard LD-CD as assessed by both the fluctuation index (primary endpoint) and the coefficient of variation (p<0.001 for both). There was significant improvement with continuous LD-CD delivered by the DopaFuse system for both On time without severe dyskinesia and Off time (p<0.001 for both). Additionally, the UPDRS Part II score (a measure of activities of daily living) was significantly improved (p=0.016).…'SynAgile is now scaling up manufacturing at its facility in San Jose, CA in preparation for a double-blind Phase 3 clinical trial of the DopaFuse system.’”

P2 data • CNS Disorders • Parkinson's Disease

SynAgile Completes Enrollment of its Phase 2 Clinical Trial of its DopaFuse Delivery System (GlobeNewswire) - "SynAgile Corporation...is pleased to announce it has completed enrollment of its clinical trial evaluating the DopaFuse Delivery System for the treatment of Parkinson’s Disease ('PD'). The clinical trial, called SCOL (Study of Continuous Oral Levodopa) is a Phase 2, open-label, multi-center study comparing the DopaFuse Delivery System to participants’ standard intermittent doses of oral levodopa. Sixteen participants with PD from five sites in Spain, Luxembourg, and Italy have completed the study."

Enrollment closed • CNS Disorders • Parkinson's Disease

SCOL: Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients (clinicaltrials.gov) - P2 | N=17 | Completed | Sponsor: SynAgile Corporation | Recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

SCOL: Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: SynAgile Corporation | Trial completion date: Dec 2021 ➔ Aug 2022 | Trial primary completion date: Dec 2021 ➔ Aug 2022

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

First Patient Treated with the DopaFuse Delivery System (GlobeNewswire) - “SynAgile is pleased to announce treatment of the first patient with the DopaFuse Delivery System in the SCOL (Study of Continuous Oral Levodopa) clinical trial. The patient was treated at the Luxembourg Institute of Health and the Centre Hospitalier de Luxembourg. The SCOL clinical trial is a Phase 2, open-label, multicenter study comparing the DopaFuse Delivery System to participants’ standard intermittent doses of oral levodopa for the treatment of Parkinson’s disease. 24 participants from approximately 6 sites in Spain, Luxembourg and Italy are expected to enroll in the study. The study is expected to complete in 2022.”

Trial completion date • Trial status • CNS Disorders • Parkinson's Disease

SCOL: Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients (clinicaltrials.gov) - P2; N=24; Recruiting; Sponsor: SynAgile Corporation; Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

SCOL: Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients (clinicaltrials.gov) - P2; N=24; Not yet recruiting; Sponsor: SynAgile Corporation

Clinical • New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Laboratory Performance of the DopaFuse® Delivery System (MDS Congress 2019) - "Objective:SynAgile has developed the DopaFuse Delivery System to noninvasively and continuously administer levodopa/carbidopa (LD/CD) into the mouths of patients with Parkinson’s Disease (PD)...Initial engineering and design verification tests show that the DopaFuse Delivery System performs as expected under laboratory conditions."